CABG suspends enrollment in Holly Graft System testing

By Ted A. Knutson

Washington, Nov. 28 - CABG Medical, Inc. announced Monday it has suspended enrollment in its international clinical trial of the Holly Graft System (HGS). A total of eight patients have been treated with an anti-coagulant regimen of aspirin and warfarin, and two of the grafts were determined to have occluded prior to the patient's discharge from the hospital.

The company previously announced that the first enrollment arm, consisting of 36 patients implanted with the Holly Graft System and treated with an anti-platelet regimen of aspirin and clopidogrel failed to meet the standards necessary to obtain regulatory approval.

"The incorporation of warfarin into the treatment regimen of HGS patients has not prevented occlusions in the limited set of patients treated with this regimen. The results are disappointing and at this time do not warrant further evaluation in clinical trials," commented Manny Villafana, the company's chairman and chief executive officer, in a news release.

Villafana added, "It appears the majority of the failures are due to graft occlusions rather than restenosis, and we will aggressively seek the cause of these failures. We are in the process of reviewing all of our clinical and preclinical data to determine whether any modifications can be made to the HGS that would reduce the occurrence of occlusion to a level necessary to meet standards required to obtain regulatory approvals. Such modifications may take up to 12 to 18 months to implement and test preclinically."

Minneapolis-based CABG is a medical technology company that develops technologies and therapies to improve the treatment of coronary heart disease by advancing conventional bypass surgery.

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